1010153 UNITED STATES OF AMERICA BEFORE THE FEDERAL …

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1010153UNITED STATES OF AMERICA

BEFORE THE FEDERAL TRADE COMMISSION

COMMISSIONERS: Jon Leibowitz, ChairmanWilliam E. KovacicJ. Thomas RoschEdith RamirezJulie Brill

____________________________________)

In the Matter of ))

GRIFOLS, S.A. ) a corporation, )

))

and ) Docket No. C-4322)

TALECRIS BIOTHERAPEUTICS ) [Redacted Public Version]HOLDINGS CORP. ) a corporation. )

))

____________________________________)

DECISION AND ORDER

The Federal Trade Commission (“Commission”), having initiated an investigation of theproposed acquisition of Talecris Biotherapeutics Holdings Corp. (“Respondent Talecris”) byGrifols, S.A. (“Respondent Grifols”), and Respondent Grifols and Respondent Talecris havingbeen furnished thereafter with a copy of a draft Complaint that the Bureau of Competitionproposed to present to the Commission for its consideration and which, if issued by theCommission, would charge Respondent Grifols and Respondent Talecris with violations ofSection 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal TradeCommission Act, as amended, 15 U.S.C. § 45; and

Respondent Grifols and Respondent Talecris, their attorneys, and counsel for theCommission having thereafter executed an Agreement Containing Consent Orders (“ConsentAgreement”), containing an admission by Respondent Grifols and Respondent Talecris of all thejurisdictional facts set forth in the aforesaid draft Complaint, a statement that the signing of saidConsent Agreement is for settlement purposes only and does not constitute an admission byRespondent Grifols and Respondent Talecris that the law has been violated as alleged in such

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Complaint, or that the facts as alleged in such Complaint, other than jurisdictional facts, are true,and waivers and other provisions as required by the Commission’s Rules; and

The Commission having thereafter considered the matter and having determined that ithad reason to believe that Respondent Grifols and Respondent Talecris have violated the saidActs, and that a Complaint should issue stating its charges in that respect, and having thereuponissued its Complaint and an Order to Maintain Assets, and having accepted the executed ConsentAgreement and placed such Consent Agreement on the public record for a period of thirty (30)days for the receipt and consideration of public comments, now in further conformity with theprocedure described in Commission Rule 2.34, 16 C.F.R. § 2.34, the Commission hereby makesthe following jurisdictional findings and issues the following Decision and Order (“Order”).

1. Respondent Grifols is a corporation organized, existing and doing business underand by virtue of the laws of Spain with its office and principal place of business at Avinguda dela Generalitat, 152, Parque empresarial Can Sant Joan, 08174 Sant Cugat del Valles, Barcelona,Spain, and with its office and principal place of business in the United States located at 2410Lillyvale Avenue, Los Angeles, CA 90032.

2. Respondent Talecris is a corporation organized, existing and doing business underand by virtue of the laws of Delaware, with its office and principal place of business located at4101 Research Commons, 79 T.W. Alexander Drive, Research Triangle Park, North Carolina27709.

3. The Federal Trade Commission has jurisdiction of the subject matter of thisproceeding and of Respondent, and the proceeding is in the public interest.

ORDER

I.

IT IS ORDERED that, as used in this Order, the following definitions shall apply:

A. “Grifols” means Grifols, S.A., its directors, officers, employees, agents, representatives,successors, and assigns; and its joint ventures, subsidiaries, divisions, groups, and affiliatescontrolled by Grifols, S.A. (including Talecris, after the Acquisition Date), and therespective directors, officers, employees, agents, representatives, successors, and assigns ofeach.

B. “Talecris” means Talecris Biotherapeutics Holdings Corp. its directors, officers, employees,agents, representatives, successors, and assigns; and its joint ventures, subsidiaries,divisions, groups, and affiliates controlled by Talecris Biotherapeutics HoldingsCorporation, and the respective directors, officers, employees, agents, representatives,successors, and assigns of each.

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C. “Commission” means the Federal Trade Commission.

D. “Acquisition” means Respondent Grifols’ acquisition of Talecris.

E. “Acquisition Date” means the date on which the Acquisition is consummated.

F. “Acquirer” means the Person specified by name in this Order, or the Person approved by theCommission, to acquire the Divested Business pursuant to Paragraph II or Paragraph VI ofthis Order.

G. “Branded Supply Date” means the date that is one hundred twenty (120) days after theAcquisition Date.

H. “Confidential Business Information” means competitively sensitive, proprietary, and allother information, solely Relating To the Divested Business, that is not in the publicdomain, owned by or pertaining to a Person or a Person’s business, and includes, but is notlimited to, all customer lists, price lists, contracts, cost information, marketing methods,technologies, processes, or other trade secrets.

I. “Contract Manufacturing Agreement” means the agreement that has been approved by theCommission and become a part of the Divestiture Agreement, under which RespondentGrifols and Kedrion have agreed to, among other things, various terms regarding theManufacturing of Products by Respondent Grifols and the sale of Products by Kedrion.

J. “Designated Amount of Products” means the confidential amount of liter equivalentProducts included in Confidential Exhibit A to this Order.

K. “Designated Employee” means the named employee, or person filling a particular jobdescription, listed in Confidential Exhibit B to this Order.

L. “Designated Melville Employee” means the named employee, or person filling a particularjob description, listed in Confidential Exhibit B-1 to this Order.

M. “Development” means all research and development activities, including, withoutlimitation, the following: test method development; stability testing; process development;manufacturing scale-up; development-stage manufacturing; quality assurance/qualitycontrol development; statistical analysis and report writing; and conducting experiments forthe purpose of obtaining any and all product approvals or certifications. “Develop” meansto engage in Development.

N. “Divested Business” means:

1. The Melville Facility;

2. The Grifols Plasma Centers;

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3. Grifols Plasma;

4. The Contract Manufacturing Agreement; and

5. All assets, tangible and intangible, property, facilities, equipment, contracts, and allother requirements necessary to fulfill Grifols’ obligations under the ContractManufacturing Agreement, the Product Agreement, and the Divestiture Agreement.

O. “Divestiture Agreement” means all the divestiture agreements, licenses, assignments, andother agreements entered into by Respondent Grifols and Kedrion for the sale of theMelville Facility, the Grifols Plasma Centers, Grifols Plasma, the Products SupplyAgreements, and all other agreements, leases, transfers, and licenses required by this Order. The Divestiture Agreement is attached as Confidential Exhibit C to this Order.

P. “Effective Date” means the date on which the divestitures, licensing, and assignmentspursuant to Paragraph II or Paragraph VI of this Order, are consummated.

Q. “FDA Approval Date” means the date on which the FDA grants all approvals necessary forKedrion to market and sell Private Label Albumin Product and Private Label IVIG Product. In the event the FDA approves the marketing and sale by Kedrion of one of the twoproducts before the other, the FDA Approval Date shall be the latter of those two approvaldates.

R. “Grifols Plasma” means normal source plasma, approved by the U.S. Food & DrugAdministration (“FDA”), supplied by Grifols, which meets the specifications set forth inExhibit B to the Contract Manufacturing Agreement.

S. “Grifols Plasma Centers” means the plasma collection facilities owned and operated byRespondent Grifols at the locations identified in Exhibit D to this Order.

T. “Kedrion” means Kedrion S.p.A. a corporation organized, existing and doing businessunder and by virtue of the laws of Italy with its international headquarters located at Loc. AiConti, 55051 Castelrechhio Pascoli, Bargra (Lucca), Italy and its principal place of businessin the United States located at Parker Plaza, 40 Kelby Street, Fort Lee, NJ 07024.

U. “Manufacture” or “Manufactured” means some or all of the fractionation, purification,formulation, filling, packaging, inspecting, validating and testing of Products, and does notinclude the commercialization activities including, but not limited to, pricing and price-reporting, sales, marketing, and/or distribution.

V. “Melville Facility” means the facility owned and operated by Talecris at 155 Duryea Road,Melville, New York 11747, and all machinery, fixtures, equipment, vehicles, transportationand storage facilities, furniture, tools, supplies, stores, spare parts, and other tangibleproperty located at or Relating To that facility.

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W. “Melville Lease Agreement” means any agreement between Respondent Grifols andKedrion for the lease of the Melville Facility.

X. “Melville Lease Termination Date” means the date on which Respondent Grifols terminatesits lease of the Melville Facility from Kedrion pursuant to the Melville Lease Agreement.

Y. “Patents” means all patents, patent applications, including provisional patent applications,invention disclosures, certificates of invention and applications for certificates of inventionand statutory invention registrations, in each case existing as of the Acquisition Date, andincludes all reissues, additions, divisions, continuations, continuations-in-part,supplementary protection certificates, extensions and reexaminations thereof, all inventionsdisclosed therein, and all rights therein provided by international treaties and conventions,Related To any product of or owned by Respondent Grifols as of the Acquisition Date.

Z. “Person” means any natural person, partnership, corporation, association, trust, jointventure, government, government agency, division, or department, or other business or legalentity.

AA. “Plasma Sales Agreement” means an agreement between Grifols and Kedrion under whichGrifols will sell blood plasma to Kedrion.

BB. “Products” means:

1. Private Label IVIG Product, Koate, or Private Label Albumin Product, in each case thatis intended for human use, Manufactured by Grifols, pursuant to instructions by Kedrionand under the terms and conditions of the Contract Manufacturing Agreement; and

2. Fraction V Paste or Cryoprecipitate, derived from plasma, Manufactured by Grifols forKedrion pursuant to the Contract Manufacturing Agreement, and delivered asintermediates to Kedrion by Grifols.

CC. “Relating To” or “Related To” means pertaining in any way to, and is not limited to thatwhich pertains exclusively to or primarily to.

DD. “Remedial Agreement” means the following:

1. the Divestiture Agreement if such agreement has not been rejected by the Commissionpursuant to Paragraph II of this Order; and

2. any agreement between Respondent Grifols and a Commission-approved Acquirer (orbetween a Divestiture Trustee and a Commission-approved Acquirer) that has beenapproved by the Commission to accomplish the requirements of this Order, and allamendments, exhibits, attachments, agreements, and schedules thereto, related to therelevant assets to be granted, licensed, delivered or otherwise conveyed, that have beenapproved by the Commission to accomplish the requirements of this Order.

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EE. “Third Party(ies)” means any Person other than Respondent Grifols, Talecris, Kedrion, orthe Acquirer.

FF. “Trade Dress” means the current trade dress of a particular product or Person including,without limitation, product packaging, logos, and the lettering of the product trade name,brand name, or corporate name.

GG. “Trademark(s)” means all proprietary names or designations, trademarks, service marks,trade names, and brand names, including registrations and applications for registrationtherefor (and all renewals, modifications, and extensions thereof) and all common lawrights, and the goodwill symbolized thereby and associated therewith, for Koate.

[Albumin Definitions]

HH. “Albumin Manufacturing Agreement” means an agreement between Kedrion andRespondent Grifols, that has been approved by the Commission and become a part of theDivestiture Agreement, under which Respondent Grifols will provide Private LabelAlbumin Product and Fraction V for Kedrion.

II. “Albumin Product” means an albumin factor derived from human blood plasma and used,among other things, as a blood volume expander.

JJ. “Designated Amount of Talecris Albumin Product” means the minimum amount of TalecrisAlbumin Product to be produced by Respondent Grifols during the Contract ManufacturingAgreement and made available for sale by Kedrion, attached in Confidential Exhibit E-1.

KK. “Fraction V” means plasma protein factor that predominantly contains albumin.

LL. “Fraction V Paste” means a plasma intermediate used in the Manufacture of AlbuminProduct.

MM. “Plasbumin” means branded Talecris Albumin Product and includes Plasbumin®-5,Albumin (Human) 5%, USP (PDF); Plasbumin®-20, Albumin (Human) 20%, USP (PDF);and Plasbumin®-25, Albumin (Human) 25%, USP (PDF).

. NN. “Private Label Albumin Product” means an Albumin Product identical to, and manufactured

according to the FDA-approved process used in the production of, the Talecris AlbuminProduct.

OO. “Talecris Albumin Customer Contracts” means contracts between Talecris and ThirdParties, including group purchasing organizations and hospitals, for the sale and purchaseof, at a minimum, the Designated Amount of Talecris Albumin Product, including but notlimited to, the contracts identified in Confidential Exhibit E.

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PP. “Talecris Albumin Product” means the Albumin Product Developed, manufactured and soldby Talecris in the United States under the brand name Plasbumin.

[IVIG Definitions]

QQ. “IVIG Product” means an intravenous immune globulin derived from human blood plasma.

RR. “Designated Amount of Talecris IVIG Product” means minimum amount of Talecris IVIGProduct to be produced by Respondent Grifols during the Contract ManufacturingAgreement and made available for sale by Kedrion, and designated in Confidential ExhibitF-1.

SS. “Gamunex” means branded Talecris IVIG Product.

TT. “Private Label IVIG Product” means intravenous immune globulin derived from humanblood plasma identical to, and manufactured according to the FDA-approved process usedin the production of, the Talecris IVIG Product.

UU. “Talecris IVIG Customer Contracts” means contracts between Talecris and Third Parties,including group purchasing organizations and hospitals, for the sale and purchase of at leastthe Designated Amount of Talecris IVIG Product including, but not limited to, the contractsidentified in Confidential Exhibit F.

VV. “Talecris IVIG Product” means the IVIG Product Developed, manufactured and sold byTalecris in the United States under the brand name Gamunex.

[Koate Definitions]

WW. “Cryoprecipitate” means a product derived from fresh frozen plasma containing coagulationfactors.

XX. “Factor VIII Product” means an antihemophilic factor derived from Cryoprecipitate used inthe treatment of, among other things, hemophilia A.

YY. “Koate” means the Factor VIII Product sold under the Talecris registered brand nameKoate.

ZZ. “Koate Option, License and Sale Agreement” means the agreement between RespondentGrifols and Kedrion granting to Kedrion, among other things, the exclusive rights to sellbranded Koate in the United States and the option to acquire non-exclusive rights tomanufacture branded Koate in the United States, Italy, and Hungary.

AAA. “Koate Customer Contracts” means all contracts between Talecris and a third party for thepurchase and sale of Koate in the United States including, but not limited to, the contractsidentified in Confidential Exhibit G.

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BBB. “Koate Intellectual Property” means all of the following Related To Koate:

1. all Talecris intellectual property used in the Development, manufacturing, storage,distribution and sale of Koate including, but not limited to:

a. Koate Manufacturing Copyrights;

b. Software;

c. computer programs;

d. Patents including, but not limited to, the right to obtain and file for Patents andKoate Sales and Manufacturing Copyrights, and registrations thereof;

e. licenses including, but not limited to, licenses to third-party Software if transferableand sub-licenses to Software modified by Respondent Talecris;

f. know-how (including, but not limited to, flow sheets, process and instrumentation),diagrams, risk analysis, certificates of analysis, goodwill, technology (including, butnot limited to, equipment specifications), drawings, utility models, designs, designrights, techniques, data, inventions, practices, recipes, raw material specifications,process descriptions;

g. technical information (including, but not limited to, material and final productspecifications);

h. protocols (including, but not limited to, operational manuals);

i. quality control information and methods, and other confidential or proprietarytechnical, business, Development and other information;

j. trade secrets; and

k. all rights to limit the use or disclosure thereof trade names, service marks, logos,and the modifications or improvements to such intellectual property; and

2. rights to sue and recover damages or obtain injunctive relief for infringement, dilution,misappropriation, violation or breach of any of the foregoing.

CCC. “Koate Manufacturing Copyrights” means copyrights in all process development data andreports Relating To the research and development of Koate, or of any materials used in theresearch, Development, manufacture, manufacturing records, manufacturing processes, andsupplier lists; all copyrights in data contained in laboratory notebooks Relating To Koate;all copyrights in analytical and quality control data; and all correspondence withgovernmental agencies.

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DDD. “Koate Sales Copyrights” means rights to all original works of authorship of any kinddirectly Related To the sale of Koate in the United States, and any registrations andapplications for registrations thereof, including, but not limited to, the following: all suchrights with respect to all promotional, marketing, sales, and advertising materials,educational and training materials for the sales force, and sales forecasting models;marketing or sale of Koate including copyrights in all raw data, statistical programsdeveloped (or modified in a manner material to the use or function thereof (other thanthrough user preferences)) to analyze research data, market research data, marketintelligence reports and statistical programs (if any) used for marketing and sales research;all copyrights in customer information; all copyrights in records, including customer lists,sales force call activity reports, vendor lists, and sales data.

II.

IT IS FURTHER ORDERED that:

A. Within ten (10) days of the Acquisition Date, Respondent Grifols shall divest the MelvilleFacility, the Grifols Plasma Centers, and Grifols Plasma, enter into the ContractManufacturing Agreement, the Product Agreement, the Koate Option, License and SaleAgreement, assign or extend rights and obligations under the Koate Customer Contracts, theTalecris Albumin Customer Contracts, and the Talecris IVIG Customer Contracts,absolutely and in good faith, to Kedrion, pursuant to, and in accordance with, theDivestiture Agreement. The Divestiture Agreement (which shall include, among otherthings, the sale and purchase agreements for the Melville Facility, the Grifols PlasmaCenters, and Grifols Plasma, the assignments, licenses, supply agreements, and all otheragreements between Respondent Grifols and Kedrion) between Respondent Grifols andKedrion shall not vary or contradict, or be construed to vary or contradict, the terms of thisOrder, it being understood that nothing in this Order shall be construed to reduce any rightsor benefits of Kedrion, or to reduce any obligations of Respondent Grifols under suchagreements, and such agreements, if approved by the Commission, shall be incorporated byreference into this Order and made a part hereof.

PROVIDED, HOWEVER, that Respondent Grifols shall be allowed, pursuant to theDivestiture Agreement, to enter into a Melville Facility Lease Agreement with Kedrionunder which, for a period of no more than four (4) years from the Acquisition Date,Respondent Grifols will lease back the Melville Facility from Kedrion. Such agreement,if approved by the Commission, shall be a part of the Divestiture Agreement andincorporated into this Order and made a part hereof.

PROVIDED, HOWEVER, if, at the time the Commission determines to make this Orderfinal, the Commission notifies Respondent Grifols that Kedrion is not an acceptableAcquirer then, after receipt of such written notification: (1) Respondent Grifols shallimmediately notify Kedrion of the notice received from the Commission and shall assoon as practicable effect the rescission of the Divestiture Agreement; and (2)

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Respondent Grifols shall, within one-hundred-fifty (150) days from the date this Orderbecomes final, divest the Divested Business, enter into manufacturing and distributionagreements, assign or extend rights and obligations under customer contracts, and divestany other assets or enter into any other relief required to satisfy the purposes of thisOrder, absolutely and in good faith, at no minimum price, to or with an Acquirer, thatreceives the prior approval of the Commission, and in a manner that receives the priorapproval of the Commission;

PROVIDED FURTHER, HOWEVER, that if Respondent Grifols has complied with theterms of Paragraphs II.A., II.B., and II.C. before the date on which this Order becomesfinal, and if, at the time the Commission determines to make this Order final, theCommission notifies Respondent Grifols that the manner in which the divestiture andassignments were accomplished is not acceptable, the Commission may directRespondent Grifols, or appoint a Divestiture Trustee, to effect such modifications to themanner of divestiture and assignments including, but not limited to, entering intoadditional agreements or arrangements, as the Commission may determine are necessaryto satisfy the requirements of this Order.

B. Prior to the Effective Date, Respondent Grifols shall secure all consents and waivers fromall Third Parties, other than the FDA, including customers whose contracts are beingassigned or extended to Kedrion pursuant to Paragraph II.A., that are necessary to permitKedrion to sell Private Label Albumin Product, Private Label IVIG Product, and Koate.

PROVIDED, HOWEVER, Respondent may satisfy this requirement by certifying thatthe Acquirer has executed all such agreements directly with each of the relevant ThirdParties.

C. Respondent Grifols shall Manufacture the Designated Amount of Products, as set forth inConfidential Exhibits A, E-1, and F-1, annually for Kedrion to market and sell suchProducts, and Kedrion will take or pay for such Designated Amount of ProductsManufactured by Grifols for seven (7) years beginning the day after the FDA Approval Dateor the Effective Date, which ever date is later;

PROVIDED, HOWEVER, that in the event Kedrion is not approved by the FDA tomarket and sell Private Label Albumin Product or Private Label IVIG Product by theBranded Supply Date, then, for purposes of Paragraph II.C., Respondent Grifols shall:(1) Manufacture Plasbumin and Gamunex for Kedrion; (2) supply Kedrion withsufficient inventory of Plasbumin and Gamunex so it can begin supplying customers withPlasbumin and Gamunex no later than three days after the Branded Supply Date, and (3)continue to supply Kedrion with Plasbumin and Gamunex so it can market and sell in theamounts set forth in Confidential Exhibits A, E-1, and F-1 of this Order.

PROVIDED, FURTHER, HOWEVER, that in the event Respondent Grifols is required tosupply Kedrion with Plasbumin and Gamunex, the requirements of Paragraph II.C. shallbegin no later than the Branded Supply Date, and continue until the earlier of (a) the

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FDA Approval Date, or (b) seven (7) years after the Branded Supply Date. In the eventthe Branded Supply Date occurs before the Effective Date, then, for purposes of section(b) of this proviso, it shall be seven (7) years after the Effective Date. If FDA Approvalis granted for Kedrion to market and sell the Private Label Albumin Product or thePrivate Label IVIG Product, then Respondent Grifols shall begin supplying Kedrionthose private label products pursuant to Paragraph II.C. in place of Plasbumin orGamunex, respectively.

PROVIDED, FURTHER, HOWEVER, that in no event shall the seven (7) yearobligations of Paragraph II.C. extend longer than seven (7) years after the BrandedSupply Date or the Effective Date, whichever is later.

PROVIDED, FURTHER, HOWEVER, that Respondent Grifols and Respondent Talecris,with assistance from the Monitor, shall use all reasonable efforts to expedite all FDAapprovals necessary for Kedrion to market and sell Private Label Albumin Product andPrivate Label IVIG Product.

D. Respondent Grifols shall divest or otherwise transfer to Kedrion:

1. The exclusive right to sell Koate in the United States;

2. The exclusive rights to the use of all Trade Dress, brand names, Trademarks, and KoateSales Copyrights Relating To Koate in the United States, including the exclusive rightsto use the brand name Koate and its derivatives in the United States;

3. All sales and promotional materials used in the United States for the sale of Koate in theUnited States;

4. At Kedrion’s option and within five (5) years of the Acquisition Date, a non-exclusivelicense to Koate Intellectual Property for use in Koate at a price agreed to in theDivestiture Agreement;

5. The right to sell the Private Label Albumin Product, or Plasbumin, if required pursuantto the Order, in the United States;

6. The right to rebrand and use all current Talecris marketing materials Relating ToTalecris Albumin Product;

7. The right to sell the Private Label IVIG Product, or Gamunex, if required pursuant to theOrder, in the United States; and

8. The right to rebrand and use all current Talecris marketing materials Relating To theTalecris IVIG Product.

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E. Respondent Grifols shall include, as part of the Divestiture Agreement, any serviceagreement in which Respondent Grifols contemplates providing services or assistance it willprovide Kedrion for the duration of the period described in Paragraph II.C., including scopeof services, term, prices, and personnel involved.

F. Any Remedial Agreement that has been approved by the Commission between RespondentGrifols (or a Divestiture Trustee) and a Commission-approved Acquirer shall be deemedincorporated into this Order, and any failure by Respondent Grifols to comply with any termof such Remedial Agreement shall constitute a failure to comply with this Order.

G. Respondent Grifols shall not terminate any agreement that is part of the DivestitureAgreement before the end of the term approved by the Commission without:

1. the written agreement of Kedrion or the Acquirer and thirty (30) days prior notice to theCommission; or,

2. in the case of a proposed unilateral termination by Respondent Grifols due to an allegedbreach of an agreement by the Kedrion or the Acquirer, sixty (60) days notice of suchtermination. PROVIDED, HOWEVER, such sixty (60) days notice shall be given onlyafter the parties have:

a. attempted to settle the dispute between themselves, and

b. either engaged in arbitration and received an arbitrator’s decision, or received afinal court decision after all appeals.

H. The purposes of this Paragraph II of the Order are: (1) to ensure that the Acquirer will havethe intention and ability to produce and sell Koate, Private Label Albumin Product, andPrivate Label IVIG Product independently of Respondent Grifols; (2) to ensure continuedsales and distribution of Koate until such time as the Acquirer has the ability to produce aFactor VIII Product at its own facilities; (3) to ensure that the Acquirer has the ability to selland distribute Private Label Albumin Product and Private Label IVIG Product until suchtime as the Acquirer has the ability to produce an Albumin Product and an IVIG Product atits own facilities; and (4) to remedy the lessening of competition resulting from theAcquisition as alleged in the Commission’s Complaint.

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III.


A. Except in the course of performing its obligations under the Divestiture Agreement or asexpressly allowed pursuant to this Order, Respondent Grifols and Respondent Talecris shallnot

1. Interfere with any suppliers, distributors, resellers, or customers of the Persons who willacquire or have acquired the Divested Business;

2. Interfere with any contracts that will be divested, have been divested, will be assigned orextended to the Acquirer, or have been assigned or extended to the Acquirer pursuant tothis Order; or

3. Interfere in any other way with the Persons who will acquire or have acquired theDivested Business pursuant to this Order or with the businesses that will be divested orhave been divested pursuant to this Order.

PROVIDED HOWEVER, that unless otherwise prohibited by the Order as part of contractassignments, nothing in this Paragraph III.A. shall prevent Respondent Grifols fromcompeting for contracts or for the trade of suppliers, distributors, resellers, or customers.

B. During the time period before the Effective Date and before the Designated Employees arehired pursuant to Paragraph VII , Respondent Grifols and Respondent Talecris shall:

1. take such actions as are necessary to maintain the full economic viability, marketabilityand competitiveness of the Divested Business to minimize any risk of loss ofcompetitive potential for the Divested Business, and to prevent the destruction, removal,wasting, deterioration, or impairment of the Divested Business, except for ordinary wearand tear. Respondent Grifols and Respondent Talecris shall not sell, transfer, encumberor otherwise impair the Divested Business (other than in the manner prescribed in thisOrder), nor take any action that lessens the full economic viability, marketability orcompetitiveness of the Divested Business. Respondent Talecris shall take all actionsreasonably necessary to protect its Trademarks and trade dress to be transferred toKedrion from Third Party complaints or challenges.

2. retain all of Respondent Grifols’ and Respondent Talecris’ rights, title, and interest inthe Divested Business;

3. maintain the operations of the Divested Business in the regular and ordinary course ofbusiness and in accordance with past practice (including regular repair and maintenanceof the assets, as necessary) and/or as may be necessary to preserve the marketability,

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viability, and competitiveness of the Divested Business and shall use its best efforts topreserve the existing relationships with the following: suppliers, vendors, distributors,customers, governmental agencies, employees, and others having business relations withthe Divested Business.

4. maintain a work force as large as, and with equivalent or better training and expertise to,what has been associated with the Divested Business as of the Acquisition Date.

5. provide Designated Employees with reasonable financial incentives to continue in theirpositions and to Develop, and manufacture the Divested Products consistent with pastpractices and/or as may be necessary to preserve the marketability, viability andcompetitiveness of the Divested Products pending divestiture. Such incentives shallinclude a continuation of all employee benefits offered by Respondent Grifols andRespondent Talecris until the Effective Date has occurred, including regularly scheduledraises, bonuses, vesting of pension benefits (as permitted by law), and additionalincentives as may be necessary to prevent any diminution of the competitiveness of theDivested Business.

C. During the time period before the Melville Lease Termination Date, Respondent Grifols andRespondent Talecris shall provide Designated Melville Employees with reasonable financialincentives to continue in their positions. Such incentives shall include a continuation of allemployee benefits offered by Respondent Grifols and Respondent Talecris until theMelville Lease Termination Date has occurred, including regularly scheduled raises,bonuses, vesting of pension benefits (as permitted by law), and additional incentives as maybe necessary to prevent any diminution of the competitiveness of the Melville Facility.

D. The purpose of this Paragraph III is to maintain the full economic viability, marketabilityand competitiveness of the Divested Business until the Effective Date, to minimize any riskof loss of competitive potential for the Divested Business, and to prevent the destruction,removal, wasting, deterioration, or impairment of the Divested Business, except for ordinarywear and tear.

IV.


A. Except in the course of performing its obligations under the Divestiture Agreement, or asexpressly allowed pursuant to this Order:

1. Respondent Grifols shall not provide, disclose or otherwise make available anyConfidential Business Information, including the terms of the Divestiture Agreement, toany Person; and

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2. Respondent Grifols shall not use any Confidential Business Information, including theterms of the Divestiture Agreement, for any reason or purpose. Among other things,Respondent Grifols shall not use such Confidential Business Information:

a. to assist or inform Respondent Grifols employees who Develop, manufacture,solicit for sale, sell, or service Respondent Grifols products that compete with theproducts divested, sold, or distributed pursuant to this Order;

b. to interfere with any suppliers, distributors, resellers, or customers of the Personswho acquired the divested businesses;

c. to interfere with any contracts divested, assigned, or extended to the Acquirerpursuant to this Order; or

d. to interfere in any other way with the Persons who acquired the divested businessespursuant to this Order or with the businesses divested pursuant to this Order.

B. The requirements of this Paragraph IV do not apply to Confidential Business Information that Respondent Grifols demonstrates to the satisfaction of the Commission, in its solediscretion:

1. was or becomes generally available to the public other than as a result of a disclosure byRespondent Grifols;

2. is necessary to be included in mandatory regulatory filings; PROVIDED, HOWEVER,that Respondent Grifols shall make all reasonable efforts to maintain the confidentialityof such information in the regulatory filings;

3. was available, or becomes available, to Respondent Grifols on a non-confidential basis,but only if, to the knowledge of Respondent Grifols, the source of such information isnot in breach of a contractual, legal, fiduciary, or other obligation to maintain theconfidentiality of the information;

4. is consented to by the Acquirer;

5. is necessary information exchanged in the course of consummating the Acquisition;

6. is disclosed in complying with this Order;

7. is information the disclosure of which is necessary to allow Respondents to comply withthe requirements and obligations of the laws of the United States and other countries;

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8. is disclosed in defending legal claims, investigations or enforcement actions threatenedor brought against Respondents or the Divested Business; or

9. is disclosed in obtaining legal advice.

V.


A. Mr. R. Owen Richards, President of Quantic Regulatory Services, LLC, shall serve as theMonitor pursuant to the agreement executed by the Monitor and Respondent Grifols andattached as Exhibit H (“Monitor Agreement”) and Confidential Exhibit H-1 (MonitorCompensation). The Monitor is appointed to assure that Respondent Grifols expeditiouslycomplies with all of its obligations and performs all of its responsibilities as required by thisOrder.

B. The Monitor Agreement shall require that, no later than one (1) day after the AcquisitionDate, Respondent Grifols transfers to the Monitor all rights, powers, and authoritiesnecessary to permit the Monitor to perform his duties and responsibilities, pursuant to thisOrder and the Asset Maintenance Order, and consistent with the purposes of this Order.

C. No later than one (1) day after the Acquisition Date, Respondent Grifols shall, pursuant tothe Monitor Agreement, transfer to the Monitor all rights, powers, and authorities necessaryto permit the Monitor to perform his duties and responsibilities, pursuant to and consistentwith, the purposes of the Decision and Order.

D. Respondent Grifols shall consent to the following terms and conditions regarding thepowers, duties, authorities, and responsibilities of the Monitor:

1. The Monitor shall have the power and authority to monitor Respondent Grifols’compliance with the terms of the Order, and shall exercise such power and authority andcarry out the duties and responsibilities of the Monitor in a manner consistent with thepurposes of the Order and in consultation with the Commission including, but notlimited to:

a. Assuring that Respondent Grifols expeditiously complies with all of its obligationsand performs all of its responsibilities as required by this Order; and

b. Monitoring any agreements between Respondent Grifols and the Acquirer.

2. The Monitor shall act in a fiduciary capacity for the benefit of the Commission.

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3. Subject to any demonstrated legally recognized privilege, the Monitor shall have fulland complete access to Respondent Grifols’ personnel, books, documents, records keptin the normal course of business, facilities and technical information, and such otherrelevant information as the Monitor may reasonably request, Related To RespondentGrifols’ compliance with its obligations under the Order. Respondent Grifols shallcooperate with any reasonable request of the Monitor and shall take no action tointerfere with or impede the Monitor’s ability to monitor Respondent Grifols’compliance with the Order.

4. The Monitor shall serve, without bond or other security, at the expense of RespondentGrifols on such reasonable and customary terms and conditions as the Commission mayset. The Monitor shall have authority to employ, at the expense of Respondent Grifols,such consultants, accountants, attorneys and other representatives and assistants as arereasonably necessary to carry out the Monitor’s duties and responsibilities. The Monitorshall account for all expenses incurred, including fees for services rendered, subject tothe approval of the Commission.

5. Respondent Grifols shall indemnify the Monitor and hold the Monitor harmless againstany losses, claims, damages, liabilities, or expenses arising out of, or in connection with,the performance of the Monitor’s duties, including all reasonable fees of counsel andother reasonable expenses incurred in connection with the preparations for, or defenseof, any claim, whether or not resulting in any liability, except to the extent that suchlosses, claims, damages, liabilities, or expenses result from gross negligence,malfeasance, willful or wanton acts, or bad faith by the Monitor.

6. The Monitor Agreement shall provide that within one (1) month from the date theMonitor is appointed pursuant to this paragraph, and every sixty (60) days thereafter, theMonitor shall report in writing to the Commission concerning performance byRespondent Grifols of its obligations under the Order.

7. Respondent Grifols may require the Monitor and each of the Monitor’s consultants,accountants, attorneys, and other representatives and assistants to sign a customaryconfidentiality agreement; PROVIDED, HOWEVER, such agreement shall not restrictthe Monitor from providing any information to the Commission.

E. The Commission may, among other things, require the Monitor and each of the Monitor’sconsultants, accountants, attorneys, and other representatives and assistants to sign anappropriate confidentiality agreement relating to Commission materials and informationreceived in connection with the performance of the Monitor’s duties.

F. If the Commission determines that the Monitor has ceased to act or failed to act diligently,the Commission may appoint a substitute Monitor:

1. The Commission shall select the substitute Monitor, subject to the consent ofRespondent Grifols, which consent shall not be unreasonably withheld. If Respondent

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Grifols has not opposed, in writing, including the reasons for opposing, the selection ofa proposed Monitor within ten (10) days after notice by the staff of the Commission toRespondent Grifols of the identity of any proposed Monitor, Respondent Grifols shall bedeemed to have consented to the selection of the proposed Monitor.

2. Not later than ten (10) days after appointment of the substitute Monitor, RespondentGrifols shall execute an agreement that, subject to the prior approval of the Commission,confers on the Monitor all the rights and powers necessary to permit the Monitor tomonitor Respondent Grifols’ compliance with the relevant terms of the Order in amanner consistent with the purposes of the Order.

G. The Commission may on its own initiative, or at the request of the Monitor, issue suchadditional orders or directions as may be necessary or appropriate to assure compliance withthe requirements of the Order.

H. A Monitor appointed pursuant to this Order may be the same person appointed as the Divestiture Trustee pursuant to the relevant provisions of this Order.

VI.


A. If Respondent Grifols has not fully complied with the obligations as required by ParagraphII of this Order, the Commission may appoint a Divestiture Trustee to divest the MelvilleFacility and the Grifols Plasma Centers (if not divested), enter into a Plasma Sales Contract,Product Manufacturing Agreements, and any other agreements, assignments, and licenses,in a manner that satisfies the requirements of this Order.

In the event that the Commission or the Attorney General brings an action pursuant to§ 5(l) of the Federal Trade Commission Act, 15 U.S.C. § 45(l), or any other statuteenforced by the Commission, Respondent Grifols shall consent to the appointment of aDivestiture Trustee in such action to effectuate the divestitures and other obligations asdescribed in Paragraphs II, III, and IV. Neither the appointment of a Divestiture Trusteenor a decision not to appoint a Divestiture Trustee under this Paragraph VI shall precludethe Commission or the Attorney General from seeking civil penalties or any other reliefavailable to it, including a court-appointed Divestiture Trustee, pursuant to § 5(l) of theFederal Trade Commission Act, or any other statute enforced by the Commission, for anyfailure by Respondent Grifols to comply with this Order.

B. The Commission shall select the Divestiture Trustee, subject to the consent of RespondentGrifols, which consent shall not be unreasonably withheld. The Divestiture Trustee shall bea person with experience and expertise in acquisitions and divestitures. If RespondentGrifols has not opposed, in writing, including the reasons for opposing, the selection of anyproposed Divestiture Trustee within ten (10) days after notice by the staff of the

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Commission to Respondent Grifols of the identity of any proposed Divestiture Trustee,Respondent Grifols shall be deemed to have consented to the selection of the proposedDivestiture Trustee.

C. Not later than ten (10) days after the appointment of a Divestiture Trustee, RespondentGrifols shall execute a trust agreement that, subject to the prior approval of theCommission, transfers to the Divestiture Trustee all rights and powers necessary to permitthe Divestiture Trustee to effectuate the divestitures required by this Order.

D. If a Divestiture Trustee is appointed by the Commission or a court pursuant to thisParagraph VI, Respondent Grifols shall consent to the following terms and conditionsregarding the Divestiture Trustee’s powers, duties, authority, and responsibilities:

1. Subject to the prior approval of the Commission, the Divestiture Trustee shall have theexclusive power and authority to divest the Melville Facility and the Grifols PlasmaCenters, enter into a Plasma Sales Contract, Product Manufacturing Agreements, and allother agreements, licenses and assignments as described in Paragraph II of this Order.

2. The Divestiture Trustee shall have one (1) year after the date the Commission approvesthe trust agreement described herein to divest the Melville Facility and the GrifolsPlasma Centers, enter into a Plasma Sales Contract, Product Manufacturing Agreements,and all other agreements, licenses and assignments as described in Paragraph II of thisOrder, absolutely and in good faith, at no minimum price, to one or more acquirers thatreceive the prior approval of the Commission and in a manner that receives the priorapproval of the Commission. If, however, at the end of the one (1) year period, theDivestiture Trustee has submitted a plan of divestiture or believes that the divestiturecan be achieved within a reasonable time, the divestiture period or periods may beextended by the Commission; PROVIDED, HOWEVER, the Commission may extendthe divestiture period only two (2) times.

3. Subject to any demonstrated legally recognized privilege, the Divestiture Trustee shallhave full and complete access to the personnel, books, records and facilities related tothe relevant assets that are required to be divested by this Order and to any otherrelevant information, as the Divestiture Trustee may request. Respondent Grifols shalldevelop such financial or other information as the Divestiture Trustee may request andshall cooperate with the Divestiture Trustee. Respondent Grifols shall take no action tointerfere with or impede the Divestiture Trustee’s accomplishment of the divestiture. Any delays in divestiture caused by Respondent Grifols shall extend the time fordivestiture under this Paragraph VI in an amount equal to the delay, as determined bythe Commission.

4. The Divestiture Trustee shall use best efforts to negotiate the most favorable price andterms available in each contract that is submitted to the Commission, subject toRespondent Grifols’ absolute and unconditional obligation to divest expeditiously and at

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no minimum price. The divestiture shall be made in the manner and to an acquirer asrequired by this Order.

PROVIDED, HOWEVER, if the Divestiture Trustee receives bona fide offers from morethan one acquiring entity for assets and businesses to be divested pursuant to Paragraph IIand if the Commission determines to approve more than one such acquiring entity, theDivestiture Trustee shall divest to the acquiring entity selected by Respondent Grifols from among those approved by the Commission;

PROVIDED FURTHER, HOWEVER, that Respondent Grifols shall select such entitywithin five (5) days after receiving notification of the Commission’s approval.

5. The Divestiture Trustee shall serve, without bond or other security, at the cost andexpense of Respondent Grifols, on such reasonable and customary terms and conditionsas the Commission or a court may set. The Divestiture Trustee shall have the authorityto employ, at the cost and expense of Respondent Grifols, such consultants, accountants,attorneys, investment bankers, business brokers, appraisers, and other representativesand assistants as are necessary to carry out the Divestiture Trustee’s duties andresponsibilities. The Divestiture Trustee shall account for all monies derived from thedivestiture and all expenses incurred. After approval by the Commission of the accountof the Divestiture Trustee, including fees for the Divestiture Trustee’s services, allremaining monies shall be paid at the direction of Respondent Grifols, and theDivestiture Trustee’s power shall be terminated. The compensation of the DivestitureTrustee shall be based at least in significant part on a commission arrangementcontingent on the divestiture of all of the relevant assets that are required to be divestedby this Order.

6. Respondent Grifols shall indemnify the Divestiture Trustee and hold the DivestitureTrustee harmless against any losses, claims, damages, liabilities, or expenses arising outof, or in connection with, the performance of the Divestiture Trustee’s duties, includingall reasonable fees of counsel and other expenses incurred in connection with thepreparation for, or defense of, any claim, whether or not resulting in any liability, exceptto the extent that such losses, claims, damages, liabilities, or expenses result from grossnegligence, malfeasance, willful or wanton acts, or bad faith by the Divestiture Trustee.

7. The Divestiture Trustee shall have no obligation or authority to operate or maintain therelevant assets required to be divested by this Order.

8. The Divestiture Trustee shall act in a fiduciary capacity for the benefit of theCommission.

9. The Divestiture Trustee shall report in writing to Respondent Grifols and to theCommission every sixty (60) days concerning the Divestiture Trustee’s efforts toaccomplish the divestiture.

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10. Respondent Grifols may require the Divestiture Trustee and each of the DivestitureTrustee’s consultants, accountants, attorneys and other representatives and assistants tosign a customary confidentiality agreement; PROVIDED, HOWEVER, such agreementshall not restrict the Divestiture Trustee from providing any information to theCommission.

11. The Commission may, among other things, require the Divestiture Trustee and each ofthe Divestiture Trustee’s consultants, accountants, attorneys, and other representativesand assistants to sign an appropriate confidentiality agreement relating to Commissionmaterials and information received in connection with the performance of theDivestiture Trustee’s duties.

E. If the Commission determines that a Divestiture Trustee has ceased to act or failed to actdiligently, the Commission may appoint a substitute Divestiture Trustee in the same manneras provided in this Paragraph VI.

F. The Commission or, in the case of a court-appointed Divestiture Trustee, the court, may onits own initiative or at the request of the Divestiture Trustee issue such additional orders ordirections as may be necessary or appropriate to accomplish the obligations under ParagraphII of this Order.

G. The Divestiture Trustee(s) appointed pursuant to Paragraph VI of this Order may be thesame Person appointed as the Monitor pursuant to Paragraph V of this Order.

VII.


A. Beginning no later than: (a) the Acquisition Date and continuing until ninety (90) days afterthe Effective Date for Designated Employees, and (b) ninety (90) days before the MelvilleLease Termination Date for Designated Melville Employees, Respondent Grifols shall, in amanner consistent with local labor laws:

1. facilitate employment interviews between each Designated Employee or DesignatedMelville Employee, as applicable, and the Acquirer, including providing the names andcontact information for such employees and allowing such employees reasonableopportunity to interview with the Acquirer and shall not discourage such employee fromparticipating in such interviews;

2. not interfere in employment negotiations between each Designated Employee orDesignated Melville Employee, as applicable, and the Acquirer;

3. with respect to each Designated Employee or Designated Melville Employee, asapplicable, who receives an offer of employment from the Acquirer:

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a. not prevent, prohibit, or restrict, or threaten to prevent, prohibit, or restrict theDesignated Employee or Designated Melville Employee, as applicable, from beingemployed by the Acquirer, and shall not offer any incentive to the DesignatedEmployee or Designated Melville Employee, as applicable, to decline employmentwith the Acquirer.

b. cooperate with the Acquirer in effecting transfer of the Designated Employee orDesignated Melville Employee, as applicable, to the employ of the Acquirer, if theDesignated Employee or Designated Melville Employee, as applicable, accepts anoffer of employment from the Acquirer.

c. eliminate any contractual provisions, non-compete, or other restrictions entered intoor imposed by Respondent Grifols that would otherwise prevent or discourage theDesignated Employee or Designated Melville Employee, as applicable, from beingemployed by the Acquirer.

d. eliminate any confidentiality restrictions that would prevent the DesignatedEmployee or Designated Melville Employee, as applicable, who acceptsemployment with the Acquirer from using or transferring to the Acquirer anyinformation Relating To the production and sales of Koate, the Private LabelAlbumin Product, or the Private Label IVIG Product.

e. unless alternative arrangements are agreed upon with the Acquirer, retain theobligation to pay the benefits of any Designated Employee or Designated MelvilleEmployee, as applicable, who accepts employment with the Acquirer including, butnot limited to, all accrued bonuses, vested pensions, and other accrued benefits.

B. Respondent Grifols shall not, for a period of two (2) years following the Effective Date forDesignated Employees, or the Melville Lease Termination Date for Designated MelvilleEmployees, respectively, directly or indirectly, solicit, induce, or attempt to solicit or induceany Designated Employee or Designated Melville Employee, as applicable, who isemployed by the Acquirer to terminate his or her employment relationship with theAcquirer;

PROVIDED, HOWEVER, Respondent Grifols may place general advertisements foremployees including, but not limited to, in newspapers, trade publications, websites, orother media not targeted specifically at the Acquirer’s employees;

PROVIDED FURTHER, HOWEVER, Respondent Grifols may hire DesignatedEmployees or Designated Melville Employee who apply for employment withRespondent Grifols as long as such employees were not solicited by Respondent Grifolsin violation of this Paragraph.

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VIII.

IT IS FURTHER ORDERED that for a period of ten (10) years from the date thisOrder becomes final, Respondent Grifols shall not, without providing advance writtennotification to the Commission in the manner described in this Paragraph VIII, directly orindirectly, acquire:

A. any stock, share capital, equity, or other interest in any Person, corporate or non-corporate,that produces, designs, manufactures, or sells Factor VIII Product, Albumin Product, orIVIG Product in or into the United States; or

B. any assets used at any time after the acquisition, or during the six (6) month period prior tothe acquisition, in the design, manufacture, production, or sale of Factor VIII Product,Albumin Product, or IVIG Product in or into the United States.

Said notification shall be given on the Notification and Report Form set forth in theAppendix to Part 803 of Title 16 of the Code of Federal Regulations as amended (hereinreferred to as “the Notification”), and shall be prepared and transmitted in accordancewith the requirements of that part, except that no filing fee will be required for any suchnotification, notification shall be filed with the Secretary of the Commission, notificationneed not be made to the United States Department of Justice, and notification is requiredonly of Respondent Grifols and not of any other party to the transaction. RespondentGrifols shall provide the Notification to the Commission at least thirty days prior toconsummating the transaction (hereinafter referred to as the “first waiting period”). If,within the first waiting period, representatives of the Commission make a written requestfor additional information or documentary material (within the meaning of 16 C.F.R. §803.20), Respondent Grifols shall not consummate the transaction until thirty days aftersubmitting such additional information or documentary material. Early termination ofthe waiting periods in this paragraph may be requested and, where appropriate, grantedby letter from the Bureau of Competition.

PROVIDED, HOWEVER, that prior notification shall not be required by this paragraphfor a transaction for which Notification is required to be made, and has been made,pursuant to Section 7A of the Clayton Act, 15 U.S.C. § 18a.

PROVIDED, FURTHER, HOWEVER, that prior notification shall not be required by thisParagraph VIII for any acquisition after which Respondent Grifols would hold no morethan one percent of the outstanding securities or other equity interest in any Persondescribed in this Paragraph VIII.

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IX.


A. Within thirty (30) days after the date this Order becomes final, and every thirty (30) daysthereafter until Respondent Grifols has fully complied with Paragraph II.A. of this Order,Respondent Grifols shall submit to the Commission a verified written report setting forth indetail the manner and form in which it intends to comply, is complying, and has compliedwith this Order. Respondent Grifols shall submit at the same time a copy of its reportconcerning compliance with this Order to the Monitor or Divestiture Trustee, if anyDivestiture Trustee has been appointed pursuant to this Order. Respondent Grifols shallinclude in its report, among other things that are required from time to time, a fulldescription of the efforts being made to comply with the relevant Paragraphs of the Order,including a description of all substantive contacts or negotiations related to the divestiture ofthe relevant assets and the identity of all parties contacted. Respondent Grifols shall includein its report copies of all written communications to and from such parties, all internalmemoranda, and all reports and recommendations concerning completing the obligations.

B. Beginning twelve (12) months after the date this Order becomes final, and annuallythereafter on the anniversary of the date this Order becomes final, for the next nine (9)years, Respondent Grifols shall submit to the Commission a verified written report settingforth in detail the manner and form in which it has complied, is complying, and will complywith this Order. Respondent Grifols shall include in its compliance reports, among otherthings that are required from time to time, a full description of the efforts being made tocomply with the Order and copies of all written communications to and from all personsRelating To this Order. Additionally, Respondent Grifols shall include in its compliancereport whether or not it made any notifiable acquisitions pursuant to Paragraph VIII.Respondent Grifols shall include a description of such acquisitions including, but notlimited to, the identity of the Person or assets acquired, the location of the Person or assets,and a detailed description of the assets or Person and its Factor VIII Product, AlbuminProduct, or IVIG Product sales or manufacturing.

X.

IT IS FURTHER ORDERED that Respondent Grifols shall notify the Commission at least thirty (30) days prior to any proposed:

A. dissolution of the Respondent Grifols;

B. acquisition of, merger with, or consolidation by Respondent Grifols; or

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C. other change in the Respondent Grifols, including, but not limited to, assignment and thecreation or dissolution of subsidiaries, if such change might affect compliance obligationsarising out of this Order.

XI.

IT IS FURTHER ORDERED that, for purposes of determining or securing compliancewith this Order, and subject to any legally recognized privilege, and upon written request andupon five (5) days notice to Respondent Grifols, Respondent Grifols shall, without restraint orinterference, permit any duly authorized representative(s) of the Commission:

A. access, during business office hours of Respondent Grifols and in the presence of counsel,to all facilities and access to inspect and copy all books, ledgers, accounts, correspondence,memoranda and all other records and documents in the possession or under the control of Respondent Grifols Relating To compliance with this Order, which copying services shallbe provided by Respondent Grifols at its expense; and

B. to interview officers, directors, or employees of Respondent Grifols, who may have counselpresent, regarding such matters.

XII.

IT IS FURTHER ORDERED that this Order shall terminate on July 20, 2021.

By the Commission, Commissioner Kovacic recused.

Donald S. ClarkSecretary

SEALISSUED: July 20, 2011

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CONFIDENTIAL EXHIBIT A

DESIGNATED AMOUNT OF PRODUCTS

[Redacted From the Public Record Version But Incorporated By Reference]

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CONFIDENTIAL EXHIBIT B

DESIGNATED PLASMA CENTER ANDSALES & MARKETING EMPLOYEES


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CONFIDENTIAL EXHIBIT B-1

DESIGNATED MELVILLE EMPLOYEES


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CONFIDENTIAL EXHIBIT C

DIVESTITURE AGREEMENT


30

EXHIBIT D

GRIFOLS PLASMA CENTERS

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PLASMA COLLECTION CENTERS

Talecris5301 Moffett Road, Suite 230Mobile, Alabama 36618

Talecris250 YWCA WayWinston-Salem, North Carolina 27101

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CONFIDENTIAL EXHIBIT E

TALECRIS ALBUMIN CUSTOMER CONTRACTS


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CONFIDENTIAL EXHIBIT E-1

DESIGNATED AMOUNT OF TALECRIS ALBUMIN


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CONFIDENTIAL EXHIBIT F

TALECRIS IVIG CUSTOMER CONTRACTS


35

CONFIDENTIAL EXHIBIT F-1

DESIGNATED AMOUNT OF TALECRIS IVIG PRODUCT


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CONFIDENTIAL EXHIBIT G

KOATE CUSTOMER CONTRACTS


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EXHIBIT H

MONITOR AGREEMENT

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CONFIDENTIAL EXHIBIT H-1

EXHIBIT E TO MONITOR AGREEMENT(COMPENSATION)


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1010153 UNITED STATES OF AMERICA BEFORE THE FEDERAL …